Vaginal SurgeriesPhase 4NCT03014778
Efficacy of Two Vaginal Solutions in Preoperative Use
A Phase 4 study testing The Chlorhexidine gluconate 0.05% and 10% Povidone iodine in people with Vaginal Surgeries, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Surgeries
- What is being tested?
- The Chlorhexidine gluconate 0.05% and 10% Povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction / removal of the stent the ureter, ureteroscopy), local or general anesthesia.
Who cannot join
- A pregnant woman or post-partum.
- A woman with known sensitivity to iodine, povidon or chlorhexidine.
- Previous pelvic surgeries within three months from the surgery planned.
- Patients taking antibiotics within one month from the surgery planned.
- Immunological failure patients.
- Patient unwilling to participate in the study.
- Patients who require the appointment of a guardian condition
- Women assigned to undergo a regular cystoscopy (no further action).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical Center
Afula, Afula, 1834111
Sharon Tzemach, DR, 972-526678244, sharon_tze1@clalit.org.il
About this study
Official title: Efficacy Comparison of Two Vaginal Solutions for Preoperative Use in Candidate Women for Vaginal Surgeries
This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.
Read the detailed description
It is well known from the literature that the use of Povidone-iodone based solution for vaginal preparation before surgery is fraught with side effects and sensitivity, and often does not provide sufficient eradication of colonies of pathogens from the operation field.
It is also known that Chlorhexidine gluconate in low concentration provides a better result and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not approved for washing the mucous membranes. This study is necessary in order to provide proof of its effectiveness and safety.
- Conditions
- Vaginal Surgeries
- Being tested
- The Chlorhexidine gluconate 0.05%, 10% Povidone iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Chlorhexidine gluconate 0.05%Drug
Also called Sterets unisept
Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%
10% Povidone iodineDrug
Washing vagina pre- operatively with 10% Povidone iodine
| Study group | Role | What they receive |
|---|---|---|
| The Chlorhexidine gluconate arm | Experimental | 35 women undergoing surgery will be vaginally pre-op washed by 0.05% chlorhexidine gluconate, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash. Receives: Drug: The Chlorhexidine gluconate 0.05% |
| The Povidone iodine arm | Active comparator | 35 women undergoing surgery will be vaginally pre-op washed by 10% Povidone iodine, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash. Receives: Drug: 10% Povidone iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in the number of colonies that grew at every stage
Measured: Before the washing, 10 minutes after washing, 30 minutes after washing.
Secondary outcomes (2)
Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.
Measured: 30 minutes after washing.
The appearance of signs of systemic allergic reactions after each bathing by looking at the mucosa, at the end of the clinical assessment.
Measured: Before the washing, 10 minutes after washing, 30 minutes after washing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vaginal SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Tzemach, HaEmek Medical Center, Israel
- Investigators
- Sharon Tzemah, MD, Principal investigator, Haemek MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014778
- Sponsor's protocol ID
- 0093-15-EMC
- Status last verified
- Feb 2018
- First submitted
- 4 Jan 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
PubMed 20054046American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
PubMed 23963423Niedner R. Cytotoxicity and sensitization of povidone-iodine and other frequently used anti-infective agents. Dermatology. 1997;195 Suppl 2:89-92. doi: 10.1159/000246038.
PubMed 9403263Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.
PubMed 7431610Kjolhede P, Halili S, Lofgren M. Vaginal cleansing and postoperative infectious morbidity in vaginal hysterectomy. A register study from the Swedish National Register for Gynecological Surgery. Acta Obstet Gynecol Scand. 2011 Jan;90(1):63-71. doi: 10.1111/j.1600-0412.2010.01023.x. Epub 2010 Nov 26.
PubMed 21275917Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
PubMed 15695981
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of Two Vaginal Solutions for Preoperative Use in Candidate Women for Vaginal Surgeries
- ClinicalTrials.gov ID
- NCT03014778
- Acronym / sponsor ID
- 0093-15-EMC
- Conditions
- Vaginal Surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Jan 2017
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.
Detailed description
It is well known from the literature that the use of Povidone-iodone based solution for vaginal preparation before surgery is fraught with side effects and sensitivity, and often does not provide sufficient eradication of colonies of pathogens from the operation field.
It is also known that Chlorhexidine gluconate in low concentration provides a better result and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not approved for washing the mucous membranes. This study is necessary in order to provide proof of its effectiveness and safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Chlorhexidine gluconate arm | Experimental | Drug: The Chlorhexidine gluconate 0.05%35 women undergoing surgery will be vaginally pre-op washed by 0.05% chlorhexidine gluconate, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash. |
| The Povidone iodine arm | Active comparator | Drug: 10% Povidone iodine35 women undergoing surgery will be vaginally pre-op washed by 10% Povidone iodine, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18
- Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction / removal of the stent the ureter, ureteroscopy), local or general anesthesia.
Key exclusion criteria (8 listed)
- A pregnant woman or post-partum.
- A woman with known sensitivity to iodine, povidon or chlorhexidine.
- Previous pelvic surgeries within three months from the surgery planned.
- Patients taking antibiotics within one month from the surgery planned.
- Immunological failure patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Chlorhexidine gluconate 0.05%Also: Sterets uniseptWashing vagina pre- operatively with Chlorhexidine gluconate 0.05% | Drug | The Chlorhexidine gluconate arm |
| 10% Povidone iodineWashing vagina pre- operatively with 10% Povidone iodine | Drug | The Povidone iodine arm |
Primary outcome
Changing in the number of colonies that grew at every stage
Time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.
2 secondary outcomes
Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.
Time frame: 30 minutes after washing.
The appearance of signs of systemic allergic reactions after each bathing by looking at the mucosa, at the end of the clinical assessment.
Time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 20054046Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
- Background: PubMed 23963423American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
- Background: PubMed 9403263Niedner R. Cytotoxicity and sensitization of povidone-iodine and other frequently used anti-infective agents. Dermatology. 1997;195 Suppl 2:89-92. doi: 10.1159/000246038.
- Background: PubMed 7431610Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.
- Background: PubMed 21275917Kjolhede P, Halili S, Lofgren M. Vaginal cleansing and postoperative infectious morbidity in vaginal hysterectomy. A register study from the Swedish National Register for Gynecological Surgery. Acta Obstet Gynecol Scand. 2011 Jan;90(1):63-71. doi: 10.1111/j.1600-0412.2010.01023.x. Epub 2010 Nov 26.
- Background: PubMed 15695981Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Tzemah, MD principal investigator
Haemek MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The Chlorhexidine gluconate 0.05% and 10% Povidone iodine in people with Vaginal Surgeries, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Tzemah, MD (97252-6678244, sharon_tze1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing in the number of colonies that grew at every stage (time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014778, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.